New MOA for depression
Targacept, Inc. (NASDAQ: TRGT), a clinical-stage biopharmaceutical company developing a new class of drugs known as NNR Therapeutics-, today announced the presentation of data from its recently completed Phase 2b clinical trial of TC-5214 as an augmentation (add-on) treatment in subjects with major depressive disorder, or MDD, who did not respond adequately to first-line treatment with the representative SSRI citalopram hydrobromide. In the trial, the add-on TC-5214 arm (TC-5214 + citalopram) outperformed the add-on placebo arm (placebo + citalopram) on the primary outcome measure, the Hamilton Rating Scale for Depression-17, or HAM-D, and all of the secondary outcome measures, with high statistical significance.
Selective serotonin reuptake inhibitors, or SSRIs, are the most commonly prescribed class of drugs for depression, but many patients do not respond well to SSRIs. The National Institute of Mental Health, or NIMH, has estimated that 14.8 million American adults suffer from MDD. In the NIMH's large-scale Sequenced Treatment Alternatives to Relieve Depression, or STAR*D, study, approximately 63% of participants did not achieve remission following initial treatment with citalopram alone.
In the TC-5214 trial, the magnitude of clinical response (change from double blind baseline after eight weeks) on HAM-D was 6.0 points greater for the add-on TC-5214 arm (13.75 point improvement) than for the add-on placebo arm (7.75 point improvement). This result was highly statistically significant (p < 0.0001) on an intent to treat basis. Highly statistically significant results (p < 0.0001) were also achieved on an intent to treat basis on all of the trial's secondary outcome measures, including the Montgomery-Asberg Depression Rating Scale, or MADRS, the Quick Inventory of Depressive Symptomatology - Self Reporting scale and assessments of irritability, disability, cognition, severity of illness and global improvement. As previously reported, TC-5214 exhibited a favorable tolerability profile in the trial.
The data from the TC-5214 trial was presented today by Geoffrey C. Dunbar, M.D., Targacept's Vice President, Clinical Development and Regulatory Affairs, at the Nicotinic Acetylcholine Receptors as Therapeutic Targets Symposium (nAChR2009), a satellite meeting of the 39th annual meeting of the Society for Neuroscience.
"This clinical trial provides compelling evidence for TC-5214 as a beneficial augmentation treatment with promise for providing relief for millions of patients who do not respond well to first-line SSRI therapy and restoring their quality of life," commented Stuart A. Montgomery, M.D., Emeritus Professor of Psychiatry at the Imperial College School of Science and Medicine, University of London. "The impressive outcomes across the efficacy measures and favorable tolerability profile demonstrated in the trial indicate the potential of TC-5214 to become the augmentation treatment of choice in depression."